N - 亞硝基馬立巴韋（產(chǎn)品編號(hào)：M076013）

1. 產(chǎn)品信息

• 產(chǎn)品編號(hào)：M076013

• 英文名：N-Nitroso Maribavir

• 英文別名：N-(5,6-dichloro-1-((2S,3S,4R,5S)-3,4-dihydroxy-5-(hydroxymethyl) tetrahydrofuran-2-yl)-1H-benzo [d] imidazol-2-yl)-N-isopropylnitrous amide

• CAS 號(hào)：N/A

• 分子式：C15H18Cl2N4O5

• 分子量：405.23

2. 優(yōu)勢(shì)

1. 結(jié)構(gòu)與馬立巴韋母核完全匹配，為專屬 N - 亞硝基基因毒性雜質(zhì)對(duì)照品；

2. 純度≥98%，理化性質(zhì)穩(wěn)定，適配痕量雜質(zhì)定量檢測(cè)；

3. 適配 LC-MS/MS、UPLC-UV 等主流分析手段，適配藥品申報(bào)全套方法驗(yàn)證。

3. 應(yīng)用

1. 馬立巴韋原料藥及制劑中亞硝胺雜質(zhì)日常質(zhì)量監(jiān)控；

2. 建立并驗(yàn)證高靈敏度亞硝胺檢測(cè)分析方法；

3. 追溯合成、儲(chǔ)存環(huán)節(jié)雜質(zhì)生成誘因，優(yōu)化生產(chǎn)純化工藝。

4. 背景描述

5. 研究現(xiàn)狀

1. 該雜質(zhì)歸為藥物相關(guān)亞硝胺雜質(zhì)（NDSRI），遵循 ICH M7 基因毒性雜質(zhì)管控指南；

2. 行業(yè)統(tǒng)一采用 LC-MS/MS 實(shí)現(xiàn) ppb 級(jí)痕量定性定量；

3. 現(xiàn)有工藝優(yōu)化方向：規(guī)避亞硝酸鹽原料、調(diào)控體系 pH、增設(shè)精制步驟抑制雜質(zhì)生成。

N-Nitroso Maribavir (Product Code: M076013)

1. Product Information

• Product Code: M076013

• English Name: N-Nitroso Maribavir

• English Aliases: N-(5,6-dichloro-1-((2S,3S,4R,5S)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1H-benzo[d]imidazol-2-yl)-N-isopropylnitrous amide

• CAS No.: N/A

• Molecular Formula: C15H18Cl2N4O5

• Molecular Weight: 405.23

2. Advantages

1. Fully consistent core skeleton with Maribavir, serving as exclusive reference standard for genotoxic N-nitroso impurity;

2. Purity ≥ 98% with stable physicochemical properties, suitable for quantitative trace analysis;

3. Compatible with mainstream analytical instruments including LC-MS/MS and UPLC-UV, supporting full method validation for pharmaceutical registration.

3. Applications

1. Routine quality control of nitrosamine impurities in Maribavir API and finished formulations;

2. Establishment and validation of high-sensitivity analytical methods for nitrosamine detection;

3. Trace the root cause of impurity formation during synthesis and storage, optimize manufacturing and purification processes.

4. Background Description

5. Research Status

1. Classified as Drug-Related N-Nitroso Impurity (NDSRI), complying with ICH M7 guideline for genotoxic impurities control;

2. LC-MS/MS is universally adopted to realize ppb-level qualitative and quantitative detection;

3. Current process optimization focuses on eliminating nitrite-containing raw materials, adjusting system pH and adding purification procedures to restrain impurity formation.